Group Preconception Care for Fertility Patients
- Conditions
- Infertility
- Interventions
- Other: Group Preconception Care
- Registration Number
- NCT05924464
- Lead Sponsor
- University of Pennsylvania
- Brief Summary
Group Preconception Care for Fertility Patients aims to translate the well-established group prenatal care model to preconception care to improve pregnancy and neonatal outcomes. In partnership with Pomelo Care (a virtual maternity care program), the investigators are conducting this study using couples at Penn Fertility Care.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 140
- Female new patient seen at Penn Fertility Care for infertility or procreative management
- Currently planning to conceive
- Intending to carry pregnancy (i.e. will not need a gestational carrier), since our project aims to implement lifestyle changes prior to conception
- Willing to be randomized to group preconception care versus usual care
- Prior infertility treatment at other practice in this initial project, we aim to focus on patients with a new diagnosis of infertility to allow time for completion of the virtual program during the diagnostic phase and early treatment phase
- Known need for gestational carrier, as above
- Planning preimplantation genetic testing for monogenic disorders or egg/embryo banking
- Non-English speaking
- Unable to complete electronic questionnaires due to lack of access to technology
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention arm Group Preconception Care Group preconception care
- Primary Outcome Measures
Name Time Method Blood pressure measurement recorded by clinician in Penn EMR From enrollment to 16 weeks Was a blood pressure measurement recorded by a clinician in Penn EMR, yes/no
Weight measurement recorded by clinician in Penn EMR From enrollment to 16 weeks Was a weight measurement recorded by a clinician in Penn EMR, yes/no
Incidence of intrauterine inseminations From enrollment to 12 months Count of intrauterine insemination treatments
Hemoglobin A1c testing results recorded in Penn EMR From enrollment to 16 weeks Was a hemoglobin A1c test performed if medically indicated (history of diabetes, BMI\>30) or felt necessary by health care provider, yes/no
Change in Anxiety screening score Enrollment, 4 months, 12 months Generalized Anxiety Disorder 7 (GAD-7) Questionnaire will be administered to both groups at enrollment, 4 months, and 12 months. The total score for the seven items ranges from 0 to 21, with 21 indicating a worse outcome
Pregnancy rate From enrollment to 12 months This includes the number of patients who become pregnant during the study period in both groups.
Time to pregnancy in days From enrollment to 12 months This includes the time until patients become pregnant during the study period in both groups.
Number of pregnant participants with occurrence of a hypertensive disorder of pregnancy Conception to delivery, approximately 9 months This will be scored yes if any of the following are noted in the medical record: gestational hypertension (blood pressure \>140/90 on 2 or more occasions at least 4 hours apart), severe preeclampsia (blood pressure \>160/110 on 2 or more occasions at least 4 hours apart, or mildly elevated blood pressures with persistent headache, scotomata, platelet count \<100,000/uL, liver function tests twice the upper limit of normal, or creatinine \>1.1 mg/dL), HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count), or eclampsia (elevated blood pressure with seizures).
Number of pregnant participants with a diagnosis of gestational diabetes Conception to delivery, approximately 9 months This will be scored yes if gestational diabletes is diagnosed. Gestational diabetes is diagnosed based on an abnormal 3-hour glucose tolerance test (1-hour test blood glucose \>135mg/dL will be followed by a 3-hour test). Two or more abnormal values on the 3-hour test is diagnostic of gestational diabetes. Cutoffs are 95 fasting, 180 at 1 hour, 155 at 2 hours, and 140 at 3 hours.
Change in Fertility-related quality of life questionnaire score Enrollment, 4 months, 12 months Fertility Related Quality of Life (FertiQOL) Questionnaire will be administered to both groups at enrollment, 4 months, and 12 months. The 36 FertiQoL items are rated according to 5 types of response scales. The total score is 100, with higher scores indicating worse fertility-related quality of life.
Change in Depression screening score Enrollment, 4 months, 12 months Patient Health Questionnaire 9 (PHQ-9) will be administered to both groups at enrollment, 4 months, and 12 months. The total score for the nine items ranges from 0 to 27 where a high score indicates a worse outcome
Incidence of in vitro fertilizations From enrollment to 12 months Count of in vitro fertilization treatments
Patient experience Enrollment to 16 weeks In the intervention arm only, brief questionnaires will be distributed after each virtual session to ask participants to rate their satisfaction with the session. Patients will also complete a cumulative evaluation at the conclusion of the sessions. These surveys will use a Likert scale with a higher score indicating a better experience.
Number of pregnant participants with preterm birth At time of delivery Preterm delivery is defined as delivery at less than 37 weeks gestational age.
Number of pregnant participants with a cesarean delivery At time of delivery In participants who become pregnant, the incidence of cesarean delivery
Number of PEC (Perinatal Evaluation Center)/emergency room visits in pregnant participants From date of conception to delivery date, approximately 9 months Total number of any presentation to the Perinatal Evaluation Center or emergency room during pregnancy
Incidence of ovulation stimulations From enrollment to 12 months Count of ovarian stimulation treatments
Number of pregnant participants with occurrences with an antepartum hospitalizations Conception to delivery, approximately 9 months This includes hospital admissions during the pregnancy for any pregnancy or non-pregnancy related complications.
Among those patients that become pregnant, score on the Edinburgh Postnatal Depression Scale Between 2 to 6 weeks after delivery Edinburgh Postnatal Depression Scale will either be abstracted from the medical record, or if not administered clinically, will be administered by the study team. The total score for the ten items ranges from 0 to 30 with a higher score indicating a worse outcome.
Miscarriage rate From enrollment up to 18 months Total number of miscarriages per participants who become pregnant in either group
Number of pregnant participants with a NICU admission From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery Infant admission to neonatal intensive care unit.
Among those patients that become pregnant, delivery length of stay From date of delivery to date of discharge from hospital postpartum, up to six weeks from delivery Length of stay from birth to discharge, measured in hours
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Penn Reproductive Research Unit, 3701 Market Street, Suite 810
🇺🇸Philadelphia, Pennsylvania, United States